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Regulatory authorities need to provide more emphasis on quality control of generic medicines.” (P4). “We are ready to prescribe generic only, but there is no mechanism to ensure that private pharmacy shop chemists would dispense right and cost-effective generic medicines. Because there are hundreds of generics with different prices are available in the market, chemists can substitute for prescribed medicine as per their wish and earn high profit margins. Clinicians working in the public sector said that they prescribe 99% medicines in generic form as the government supplies only generic medicines to public health facilities.

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The prepared sample was filtered using a 0.45 μm membrane filter and injected into a chromatograph in duplicate. The chromatographic achievements and relationship models were developed using a licensed version of SPSS 28.0 (SPSS Inc., Chicago, IL, USA). Sequentially, the assay result biasness was ± 5%, and the quantitative value of genotoxic impurities equal to or more than threshold of toxicological concern limit was counted as acceptable quality attributes for AMLO besylate-containing FPPs. The European Parliament has similarly recognized the importance of medicines as global public goods, and it has repeatedly called on the Commission to exclude TRIPS-plus requirements in trade negotiations — much like in its 2021 resolution to ensure all HIV antiretroviral treatments are affordable.

• According to an article in medical journal International Health, its production is entirely dependent on three Chinese API manufacturers.
• The Indian Government in its interim Budget for financial year 2024–2025 has allocated an amount of Rs 90,658.63 crores to the Ministry of Health, which constitutes a 12.59% increase from last year, reflecting the Government’s prioritisation of development of the Indian healthcare system.
• Drug reimbursement policy has a substantial impact on the pharmaceutical industry, since it affects the incentives and outcomes of pharmaceutical research and development.
• Branded medications typically command higher prices due to factors such as high R&D costs, patent protection, post-marketing surveillance, and marketing expenses, which generally grant them monopolistic control over the market.
• Among the medicines included in the survey, 22 are universal medicines, which are supposed to be available at all levels.
• This is the first limitation of the research, thus, further investigations expanding the range of the data under examination would improve the reliability of the results.

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The five medicines chosen were alprazolam, (0.25 mg), cetirizine (10 mg), ciprofloxacin (500 mg), fluoxetine (20 mg), and lansoprazole (30 mg). The lack of well-established linkages between procurement and logistics often results in inefficient inventory management practices (temperature control, storage space, adherence to stock movement protocols, IT- enabled inventory management). Additionally, poor quality assurance mechanisms (empaneled labs for testing, accreditation, timely reporting), and insufficient supply down to the district and peripheral level facilities were observed in some states. The analysis of marketed AMLO containing FPPs was exercised using a validated analytical method. For each selected brand of AMLO FPP, two strips containing 20–30 tablets (in total), were taken. Further, individual tablets were weighed, triturated followed by weigh equivalent to 2.0 mg of AMLO besylate was taken and diluted to 20 mL with selected diluent.

Medicine pricing in India

Hence, the critical issues that affect the quality of generic drugs are purity, potency, stability, and drug release, and these should be controlled within an appropriate limit, range, or distribution to ensure the desired drug quality. EHR systems with e-prescribing capabilities help providers identify cost-saving opportunities, such as more affordable generic or therapeutic alternatives. With additional tools like coupon finders, EHR systems can locate the best local prescription prices and provide real-time data for drug-specific directions, enabling providers to offer more personalized and budget-friendly care.

Costs and affordability

The purpose of this research is to anchor the debate on the relationship between the cost of medicine and the availability and affordability of quality generic medicines in mid to low-income countries. FDA Commissioner Robert Califf admitted as much last year, when he warned that “there’s not enough reserve and supply” of generic drugs in the United States. Califf admitted that the stakes are too high (i.e. patients are sicker for longer and some are even dying due to drug shortages) he said the economics of the industry need to be altered to boost domestic production of generic drugs. Finally, the study has revealed in a current and future scenario analysis that the overall situation of the Indian pharmaceutical industry is positive at the economic, business and commercial levels, even though with many concerns. Most likely, however, the real challenge of the sector will entail a sustainable compromise between the legitimate expectations of innovative growth from the business point of view and the fundamental exigencies of affordable health from a social point of view.

Product

In India, the pharmaceutical market is majorly dominated by generics, accounting for 78.33% of all drugs in the Indian market, while patent-protected drugs account for 21.67% of the market share, according to GlobalData’s Price Intelligence (POLI) database. India sees the second most significant generic market penetration in the Asia-Pacific (APAC) region, just behind Malaysia. One reason could be that the country’s pharmaceutical price controls measures generally disincentivise pharma companies from developing novel originator medicines while incentivising the production of generics. This policy works in India’s favour, however, as the country is one of the leading producers and exporters of generics globally. The use of generic drugs is steadily increasing internationally as a result of economic pressure on drug budgets.

• Competition has been so fierce it’s driven down the cost and spurred thousands to be tested.
• That refers to testing done for the presence of active ingredients or unwanted impurities, both of which can have a direct impact on whether a drug does what it is supposed to do, experts say.
• Despite India’s contribution to global access to medicines, the government has never tried to use this as an instrument of foreign policy.
• We have used a mixed-methods approach, with the survey-based quantitative component supplemented by a qualitative component consisting of in-depth interviews (IDIs).
• Medicine prices are under the purview of Department of Pharmaceuticals which itself is under ministry of chemicals and fertilizers.
• By making intelligent connections between your needs, our capabilities, and the healthcare ecosystem, we can help you be more agile, accelerate results, and improve patient outcomes.
• There is a need to reserve appropriate sizes of land for the health-care sector in cities and for pharmaceutical companies in industrial belts during the planning process.

Do all drugs have generic versions?

In a country notorious for unsafe drinking water, they found Dr. Reddy’s has no way to ensure the water used to make the ingredients forming part of medications taken by Canadians is free of biological contamination. Delightaid health ibrutinib cost uk will not responsible for any consequences, effects or harm caused due to avoiding professional medical advice from certified doctors. Before sending the shipment, the prescription will be fully checked by our qualified Pharmacist.

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Third, the unemployment rate is quite high (6.5%) and absolute poverty is widespread in the country (23%) [33]. As a large section of the population continues to live in hand to mouth condition, the PMBJP medicines may still be unaffordable to many people. Findings of the present study indicate that both the branded and branded-generic versions of the five “paired” medicines had identical quality and they fulfilled all the criteria prescribed by the statutory standards. Hence, the general notion and doubt regarding the quality of the branded-generic version of medicines needs to be erased conducting more such studies and publishing them widely.Suitable changes in the drug price policy may be made to have lower prices for branded-generic versions.

Enzalutamide Bdenza 40 mg Price in India

• As a result of Covid-related factory shutdowns in Shanghai, China in early 2022, GE Healthcare was unable to produce enough contrast dye to supply the American market.
• Moreover, patented drugs are not immediately subject to price control and entitled to a five-year exemption from the date of marketing.[vi]  Only essential and life-saving medicines, i.e. ‘controlled/scheduled drugs’ are subjected to price regulation by the NPPA as per the provisions of the DPCO.
• The mean drug availability at PMBJP stores located in the vicinity of PHCs and district/rural hospitals was 51% and 61% respectively.
• The physicians, especially those from the rural Palghar district wondered why the generic drug stores are not opened in rural areas where it is needed more.
• Generic Aadhaar has brought a revolution in this conventional pharmaceutical industry.
• This will be a tough balance to achieve, but it appears that all stakeholders recognize the urgent need for it to occur.
• She is scientific coordinator for the CNR on R&D projects and has published articles on national and international journals, as well as essays on collective volumes.
• GlobalData examined a similar price increase for 146 essential medicines in Pakistan under the hardship category to subsidise the rising cost of active pharmaceutical ingredients (APIs) and production, which led to an acute nationwide shortage of essential drugs.
• While the upward revision of drug prices is positive for their respective producers, patients must increase their out-of-pocket (OOP) spending to cover the increased prices.

This is because in India, there is an inadequate R&D infrastructure and lower industry-academia connection for research. As mentioned above, DPCO establishes the various pricing parameters according to which the price is to be decided, and this policy reduces the profitability of the companies that would invest in innovative drugs, which requires huge capital. This sector has been hamstrung by a lack of product patents, due to which foreign companies do not introduce new drugs in the Indian market, discouraging innovation and drug discovery.

EVALUATION OF PRICE DISPARITY AMONG GENERIC MEDICINES IN INDIA

Given the role of various interlinking factors, states need to establish robust procurement systems, strengthen the existing infrastructure, ensure adequate HRH backed with robust HRH policy, expand the range of services, and strengthen CPHC for supporting holistic efforts. An overall health system strengthening is the way forward to expedite the realization of universal access to free essential medicines at public health facilities. As previously mentioned, the AYUSH Ministry was formed in 2014 for the development and spread of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy treatments. Earlier, it was known as the Department of Indian System of Medicine and Homeopathy (ISM&H), founded in 1995.

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• While each of these cost reduction initiatives has some merit, the challenge will be to reign in prescription drug costs without removing all of the financial incentives that have helped to make our domestic pharmaceutical industry a world leader and critical part of the U.S. economy.
• Now, the advantages that have enabled India to play this role are in danger of being eroded.
• Nevertheless, they claimed that generic medicines are not as effective as branded medicines.
• Indians mainly rely on private purchases for healthcare including medicine, and the country’s low public spending on health at 1.3% of GDP coupled with majority of people being either uninsured or underinsured makes this especially unaffordable for the poor [25].
• Similarly, the threats possibly deriving from other low-cost countries – China above all – are real.
• Third, the unemployment rate is quite high (6.5%) and absolute poverty is widespread in the country (23%) [33].
• Interestingly, 1 in 10 Gen Z and Millennial Americans said they base their preference for brand names on the packaging alone — that’s some pretty effective product design at work.

Ask your doctor to write a prescription allowing the pharmacist to substitute a generic drug when it’s appropriate. PTR is the price at which wholesaler (distributor) sells the product to the retailer and the bill (voucher) given to retailer by wholesaler mentions the PTR. This price was checked and confirmed from Form V (under DPCO, 1995) available at the distributors of the company. It is mandatory for all the companies to give Form V that gives details of the product with MRP, PTR, taxes paid, etc to their distributors. Qualified standards of AMLO besylate were purchased from Sigma-Aldrich (Bangalore, India). For the experiment purpose, nine top-selling AMLO containing FPPs were purchased from local pharmacy outlets in Guwahati (Assam, India).

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• Only qualified allopathic doctors and the pharmacists registered under the state or central pharmacy council were considered for IDIs.
• So to start with, we have taken both branded and branded-generic products of the same company and studied not only the quality but also the price structure.
• Some also questioned whether generics are FDA-approved (7% of Gen Z), and 12% of Millennials believed that generics took longer to work compared to brand-name medications.
• In fact, the physicians have also cited other reasons for not prescribing generic medicines.
• The world’s supply of generic medicines is a lifeline for the Global South — and this is more important than the profits of a handful of companies.
• We found that, in spite of the awareness campaign by the PMBJP, physicians, especially those having private practice remained apprehensive regarding the therapeutic efficacy and the quality of unbranded generic medicines.
• FDA approvals are considered benchmarks across many countries; therefore, these authorizations are very important for Indian pharmaceutical industries for the access, export, presence and profit they represent at the global level.

Furthermore, the physicians expressed the need for developing a regulatory framework to contain the proliferation of brands by the firms operating in the Indian pharmaceutical market, which, according to them, pose a barrier in prescribing generic medicines. Some brands of antibiotics are found to be more effective as compared to their generic counterparts. For example, augmentin brand gives effective and quick results as compared to its simple generic amoxicillin clavulanate version. But generic medicines for diabetes and hypertension are very good and cost effective for the patients for chronic illnesses.” (PuP3).

A challenge is also posed by the exponential growth in population, and epidemiological changes in the population resulting from shift in lifestyles. Thus, there is a continuous boost in the demand for pharmaceutical products and a consequent strain on the supply chain. The growth in population also affects reimbursement policies, since the Government has to allocate an increasing number of funds to public health insurance schemes and may be affected by budgetary constraints.

State- level autonomous bodies and state government- owned agencies are empowered to procure and distribute 80 per cent to 100 per cent of medicines and diagnostic products of the total requirement. Additionally, existing resources like untied funds or funds from rural/urban local governing bodies support the facilities to undertake local purchases to meet emergency demand or shortages. While the procurement mechanisms are usually centralized, logistics and distribution are widely channelized through regional and/ or district- level distribution centers like warehouses, central medical store depots or district medicine stores. EU negotiators should drop TRIPS-plus proposals, and entirely avoid them in future negotiations with developing countries. The world’s supply of generic medicines is a lifeline for the Global South — and this is more important than the profits of a handful of companies.

In a nutshell, with Paleno making its way into Indian medicine markets, the availability of Palbociclib is manifolded. With these generic drug versions by Indian brands, Breast Cancer patients with HR +ve, HER –ve have hope as they have better access to affordable treatment opportunities. The Indian medicine market has recently witnessed the launch of Palbociclib’s generic version – Paleno.

“Established in 1992, BPI has a proven track record in the research & development and manufacturing of oral solutions, suspensions and suppositories,” underlined Jinesh Shah, director at Torrent Pharma. Given the interlinkages within various systemic processes, a move towards improving access to essential medicines must be subsumed under overall health systems strengthening across the states. Education curricular changes sensitizing providers on generic medicines, rational prescription, STGs/STPs, and continuum of care can mitigate undesirable practices. In Jordan, for instance, between 2002 and 2006, the less expensive generic alternatives of 79 percent of medicines were delayed by data exclusivity, threatening the financial sustainability of government public health programs. Similarly, Guatemalans found themselves unable to access medicines readily available in most countries at affordable prices, as Guatemala is bound by data exclusivity clauses in its free trade agreement with the United States. This is a statin or blood-thinner used by millions of patients at risk of cardiovascular disease.

Sun Pharmaceutical: PALENO (Palbociclib)

In fact, we did carry out prescription audit as part of the overall study, but its findings are not included here. The present study adopted descriptive cross sectional research design to assess the current situation of PMBJP scheme in two districts of Maharashtra. However, to fully understand whether rebranding of JAS as PMBJP improved the accessibility of essential medicines, a pre/post evaluation study would have provided better insights but that could not be performed due to the non-availability of comparable baseline survey data. Hence, N X P gave the total number of drugs in that therapeutic category which were surveyed at all PMBJP pharmacies at PHC level in Palghar. For instance, if availability of 7 (N) antimicrobials medicines in 02 PMBJP pharmacies (P) at PHC level in Palghar was evaluated, then overall 14 units (PXN) would be examined.

In the USA substitution is allowed and patients accept generic substitution if physician approves of the same. Generic substitution rates have increased remarkably there, probably due to greater acceptance by physicians and pharmacists as well as encouragement from the third party payers.[20]Cheaper generics are one of the important factors to reduce health-care cost. Studies involving comparative evaluation on quality of branded and their generic counterpart may be made mandatory for the generic (or branded-generic) manufacturer and their reports should be made public to promote generic use and prescriptions. Unlike developed countries, people in developing countries pay the cost of medicines out-of-pocket. Universal access to medicines, a critical component of Sustainable Development Goals, is intended to ‘ensure access to safe, effective, quality and affordable essential medicines for all [24].